MHRA NIMAR Guidance Updated MHRA has published an updated version of the the Northern Ireland MHRA Authorised Route (NIMAR) guidance. This update includes revisions related to advertising and promotions, as well as information aligned with the Windsor Framework. NIMAR provides a route for the lawful supply of Prescription-Only Medicines in compliance with UK and EU rules, where there is a risk that clinical need in Northern Ireland for that product cannot be met. MHRA NIMAR Guidance Updated
MHRA RegulatoryConnect Webinar MHRA will be hosting a webinar on RegulatoryConnect on Thursday 22 May between 3.30-5pm. The aim of the webinar is to provide a comprehensive update on the programme, share plans for 25/26 and discuss some of the changes users will see, to help them prepare for the next release. MHRA also plan to share ongoing opportunities for feedback and involvement. MHRA RegulatoryConnect Webinar
Statutory Fee Increase and Action Required in DORS From Q1 financial year 2025/26, the medical devices registration fee will rise from £240 to £261. Ahead of this change, companies must submit any draft (TEMP) applications in DORS, otherwise they will be deleted the day prior. Statutory Fee Increase and Action Required in DORS
17th Notified Body Designated Under EU IVDR Norway based Notified Body ‘DNV Product Assurance AS’ has become the 17th Notified Body under the EU IVDR.. 17th Notified Body Designated Under EU IVDR
AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products Greece has submitted a CLH Registry of Intention for Ethanol hazard classification including Repr. 2. To explore the potential impact of a CMR1A or CMR1B classification on self-care products, AESGP is hosting a webinar on Thursday 15 May 12.30–13.30 CEST. AESGP Webinar – Ethanol BPR & CLP Procedures Impact on Self-care Products
New MHRA MedTech Blog Post MHRA has published the April edition of the MedTech blog. New MHRA MedTech Blog Post
Medical Devices: List of UK Approved Bodies Eurofins E&E CML Limited has been added to the list of UK approved bodies for medical devices. Medical Devices: List of UK Approved Bodies
16th Notified Body Designated Under EU IVDR Belgium based Notified Body ‘SGS Belgium NV’ has become the 16th Notified Body under the EU IVDR. 16th Notified Body Designated Under EU IVDR
15th Notified Body Designated Under EU IVDR Italy based Notified Body ‘IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.’ has been notified as the 15th Notified Body under the EU IVDR. 15th Notified Body Designated Under EU IVDR
Team-NB Position Paper on European Artificial Intelligence Act Team-NB has published a Position Paper on the European Artificial Intelligence Act. Team-NB Position Paper on European Artificial Intelligence Act
MHRA Clinical investigations Guidance Update The MHRA has updated its guidance on notifying the agency of an intention to conduct a clinical investigation for medical devices. The revised guidance now includes a dedicated document specifically for manufacturers. MHRA Clinical investigations Guidance Update
UK Clinical Trials Regulations Signed into Law New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out began on 11 April to deliver a significant update to UK clinical trials regulation, with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research. UK Clinical Trials Regulations Signed into Law
